The Arrhythmia Service of St. Luke's-Roosevelt Hospital has become the first center in New York City to have the Spectranetics Laser Sheath” with the CVX-300 Excimer Laser for the removal of chronic pacemaker and defibrillator leads. This laser catheter, which obliterates the scar tissue binding these leads, represents a significant advance in lead removal technology making extraction procedures safer and easier to perform. This technology has become available to the Arrhythmia Service through its participation in the Pacing Lead Explant with Excimer Sheath (PLEXES) Trial. 

Background 

Historically, extraction techniques, such as placing acute or chronic tension (pulling) on leads, have frequently resulted in lead breakage and/or life-threatening complications. Often, the end result of these percutaneous attempts was full-blown surgical extraction requiring thoracotomy and extensive intrathoracic vascular surgery along with its associated morbidity and mortality. More recently, a commercially available transvenous extraction system has been utilized. This system has a "locking stylet", which allows tension to be transmitted to the tip of the lead, and a series of telescoping sheaths, which shear away scar tissue encompassing the lead along its length. While this system offers a significant improvement over previously existing methods, success with the technique is far from universal. Procedures utilizing this system can be arduous and require significant fluoroscopic exposure. In addition, the shearing forces used are not completely controllable and as a result complications are not rare. 

Laser Technology 

The Spectranetics Laser Sheath” offers a revolutionary approach to lead removal. This catheter sheath is advanced over the pacemaker or defibrillator lead; when scar tissue is encountered, the laser is activated and the scar tissue at the catheter tip is vaporized. Data obtained during the FDA approval process for the 12 F laser sheath catheter shows that complete lead removal has been successful in 94% of attempts as compared to 65% with the conventional system (p=0.001). In addition, the inability to pass the scar tissue binding site and lead breakage occurred less frequently in the laser-treated group. Larger laser sheath catheters (14F and 16F), which are necessary for the removal of larger pacing and defibrillator leads, are not yet FDA-approved. As such, the larger catheters are only available through the PLEXES trial, in which the Arrhythmia Service is participating. The availability of this technology offers significant potential advantages for patients requiring the extraction procedure; referrals can be made by contacting the Arrhythmia Service office. 

Expanding Indications for Lead Removal 

Technologic changes are expanding the indications for pacemaker and defibrillator lead extraction. As device-based therapy (including both pacemakers and ICDs) predominates much of arrhythmia management, more devices are being implanted. Lead systems which fail or provide inadequate function may consume precious venous access or myocardial surface. Larger lead systems, such as those utilized for ICDs, are incompatible with multiple intravenous and intracavitary leads. Furthermore, abandoned leads have the potential to interfere with the function of newer lead systems by creating electrical chatter or energy shunting. 

The safer and more effective technology of lead extraction also allows broader use of the procedure. When thoracotomy procedures were necessary, extraction procedures were reserved for only the most life-threatening situations (i.e. intractable sepsis). As less invasive and safer extraction procedures became available, a risk-benefit analysis allows the physician to utilize lead extraction as a treatment option. Considering the technology available to its staff, The Arrhythmia Service considers the list in the table on this page to be the currently acceptable indications for lead explantation. 

Current Indications for Pacemaker and ICD Lead Removal 

Mandatory: Septicemia, Endocarditis, Lead Migration, Venous Access, Device Interference

Necessary: Vein Thrombosis, Severe Tricuspid Insufficiency, Pocket Infection Chronic Draining Sinus, Lead Replacement,. Erosion

The Spectranetics Laser SheathTM, now available to the Arrhythmia Service at St. Luke's-Roosevelt Hospital Center, offers a revolutionary approach for removing chronically implanted pacemaker and defibrillator leads by combining conventional technology with the photo-ablative energy of the excimer laser. (Used with permission of the Spectranetics Corporation.)

Reproduced with permission. Published by the Arrhythmia Service of St. Luke's-Roosevelt Hospital Center, New York, New York.